Life Sciences Growth Series: Medical Device Update for 2024

Join us for the 2024 kickoff of the Morgan Lewis Life Sciences Growth Series! Following the anticipated industry changes from the J.P. Morgan Healthcare Conference (JPM), this edition will analyze new trends and regulations in the medical device industry that intersect with the US Food and Drug Administration’s (FDA’s) regulation of drugs/biologics.

Drug/biologic innovators need to be aware of how FDA regulates diagnostics as medical devices. With evolving regulations planned by FDA for 2024 and beyond, understanding how devices are regulated is crucial for escalating the timeline for bringing new therapies to market. In this webinar, partners Dennis Gucciardo and Laurie Burlingame will discuss how to handle these regulatory changes and path-to-market challenges.

Topics will include:

• Understanding how FDA regulates companion diagnostics
• Changes to how FDA regulates in vitro diagnostics (IVDs) and their impact on the pharmaceutical/biologics industry
• FDA's regulation of digital health/artificial intelligence (AI) products and its intersection with the pharmaceutical/biologics industry
• Status of the medtech and diagnostics market and predictions for 2024

To request a recording of the presentation or the associated slide deck, please contact arthur.dowers@morganlewis.com.